On May 9, 2018, the U.S. Food and Drug Administration (FDA) posted a supply notification about EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, on its website to provide greater transparency and confirm that the product remains available.

As the website posting states, there are intermittent supply constraints; however, product is available and Mylan is currently receiving continual supply from its manufacturing partner Meridian Medical Technologies, a Pfizer company. Mylan is expediting shipment to wholesalers upon receipt, and supply levels may vary across wholesalers and pharmacies.

Mylan and Pfizer take the supply of EpiPen and EpiPen Jr Auto-Injectors very seriously. Pfizer manufactures both the branded and authorized generic versions and Mylan is the distributor.

A few months ago, Mylan informed FDA of intermittent supply constraints due to manufacturing delays from Pfizer. Since this time, Mylan and Pfizer have remained in close contact with FDA to provide regular updates on the inventory status.

Our first priority is to ensure patients with a life-threatening allergy have access to epinephrine auto-injector products. We encourage patients who are experiencing difficulty accessing product to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies. Hours of operation are Monday through Friday, 8 a.m. to 5 p.m. ET.

Attachments

  • Original document
  • Permalink

Disclaimer

Mylan NV published this content on 09 May 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 09 May 2018 11:50:05 UTC